SS 06Dec2017

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Meeting Record

When: 10:00 am - 11:00 am, 06Dec2017
Place: Teleconference
Facilitator: Hanming Tu
Scribe: Hanming Tu
Attendance: Steve, Mary, Wendy, Peter, Jared, Hanming
Excused: Alfredo

  • Project Update for PhUSE SC
    • Need for the update page
  • New project proposal
  • PhUSE US Annual Conference 6/3~6/2018
    • Abstract submission is open; deadline 12/1/2017
    • Whitepaper: Nhi/Terry Walsh/Peter - Mary already submitted
    • Script Repo: Hanming/Gustav
    • Education: Jared
  • CDISC InterChange
    • Abstract submission is open; The deadline for submission of abstracts is 12 January 2018
  • PhUSE/CSS conference 4~6 March, 2018
    • Deadline for posters is January 12, 2017
    • Provide two people for IOC rate: project leads who do not submit a poster: Gustav, Rebeka, Andy, and Hal.
    • Workshop Description
 This session will explore the repository in the GitHub environment, looking at the targets (TFL) defined 
 in the whitepapers, the scripts developed for the targets, the guidelines for qualifying scripts, the steps 
 for contributing scripts and a new way of accessing, sharing and executing scripts with script 
 metadata using R phuse package.
    • Whitepaper: Mary
    • Test Datasets: Peter
    • Script development: Gustav
    • Repo: Hanming
    • Capacity planning: Wendy
Crowd-sourcing an interactive Safety Review Tool
  • Next step - Mat, Steve, Mary will meet to think about next steps, some momentum for R Shiny
  • It is overlapped with Data Visualization project team and we will keep tacking how DV progress on this.
Document Versioning
  • It may be discussed in the CSS discussion club.
  • We just need to tack on this and will participate in using the tools selected
Project Update
  • P01 - SDA: Script discovery and acquisition (Rebeka M Revis; Alfredo Rojas)
    • Version 1.1 FDA contributed white paper has been finalized and uploaded to the Deliverable Catalog, we'll update links once we know the exact format of the document name
    • Need to remind JumpStart reps that they were going to tell us which scripts are used more than others; we got back from the rep: they are equal.
    • Lina will provide an update in PhUSE EU annual conference 2017
    • No update this time
    • Wendy - Reach out to Rebeka and Alfredo to get update (WD reached out to Alfredo, awaiting reply)
  • P02 - RCD: Repository content and delivery (Gustav Bernard; Andrew Miskell; FDA Liaison: Mat Soukup)
    • Focusing on outliers/shifts white paper: move a little slower during summer and will pick up speed
    • Formed one team to work on scripts:
    • Formed an R team (currently have 4): a repository was created and finished 1st three functions.
    • Slow but make progress on graph and input data: 3 R scripts uploaded in github; could not install through install.package; individual script can be downloaded through github.
    • Status: CT 7 of 7 finished; 3 of 7 R script finished; SAS started 1 of 5 outlier shift scripts
  • P03 - RGI: Repository governance and infrastructure: (Mike Carniello and Hanming Tu)
    • Focused on getting the test server: the server is created and has been used by Tim W.'s team.
    • Cross-industry R group has nice front-end to get ideas from
    • Hanming provided update on the paper and demonstrated the phuse R package
  • P07 - CPE: Communication, Promotion and Education (Jared Slain and Wendy Dobson)
    • Updated the wiki pages and added posters and events
    • Create an educational series on analytical and statistical methods from the white papers
    • Create a forum or chat for communicating
    • Jared/Wendy has updated the list of up-coming conferences under the P07 project
    • Wendy has updated CPE page and added Brenda Crowe video to CPE project, Deliverables and distributed via Youtube Media
    • Susan Duke jointed the last call and had some interesting discussion
    • Mary: one video targeted before March 2018
  • P08 - ADW: Analysis and Display White papers (Mary Nilsson)
    • Have a big goal on Q3 and Q4
    • Working on asking MedDRA MSSO to take back creating gender- and pediatric-specifics lists
    • Making progress on the AE; DM and the deposition are on target.
    • ASA group might be able to help
    • V2: plan to have DM/DS/Medication done before March 2018
  • P09 - TDF: Test Data Factory (Peter Schaefer)
    • Github has a size limit - running into data that is bigger than the limit (20 mb?)
    • We need to talk about the "dirty data" in the future meeting; we may not clean the CDISC data but we need to be able to simulate the "dirty data" so that we could demo the tools to identify the "dirty data"
      • the pilot data are not cleaned at current version; we just document them.
    • The updated datasets are uploaded into github.
    • SDTM is complete and plan to get ADaM dataset done before March 2018
    • Plan to create DefineXML based on SDTM and ADaM
    • Got one volunteer - Tanya Walton - 6 people total now
Action items
  • Hanming/Mary to provide two names for IOC rate for PhUSE/CSS conference
  • Mary/Hanming/Jared/Peter: to submit poster abstracts to PhUSE/CSS before 1/12/2018